U.S. Patent Publication Nos. 2005/054996 and 2005/137526 describe fecal management appliances in the form of elongate tubular elements. Each tubular element includes an inflatable balloon at the distal end, for anchoring the distal end in an operative position in the wearer's rectum. The tubular element includes a main drain passage, and two small-size auxiliary lumens, similar to each other and integrated into the wall of the drain passage. One of the lumens communicates with the balloon for passing inflation fluid between the balloon and an inflation port during inflation and deflation. The other of the lumens has an open end for injecting irrigation fluid from an irrigation port directly into the rectal cavity. The tubular element is collapsible in diameter, to facilitate passage through the anal sphincter. US-A-2005/054996 in particular emphasizes the significance of controlling carefully the inflation pressure in the balloon, to provide good anchoring in the rectum, while still ensuring normal blood perfusion in the soft tissue contacted by the balloon, and avoiding pressure necrosis of the soft tissue. In one form, pressure level indicators are used on the inflation lumen to provide a clinician with important indication of pressure. The pressure level indicators include a separate pressure sensor coupled to the inflation lumen near the inflation port, or a pressure indicator integrated in an inflation syringe, or spring loading the inflation syringe to act as a pressure stabilizer and indicator. The point at which a desired inflation pressure is reached, with respect to the volume of inflation fluid used, is also an important characteristic used by the clinician to assess whether the balloon is a correct size for a rectal cavity of the wearer. If an inflation pressure threshold is reached too quickly, this indicates that the balloon is too large; if an inflation pressure is never reached, this indicates that the balloon is too small.
Although not described explicitly in the above published applications, there are also several constraints affecting the size of the auxiliary lumens in the designs illustrated in these applications. Whereas the main tubular element is intended to be collapsible in diameter to facilitate passage through the anal sphincter, the auxiliary lumens have a small non-collapsing form to permit application of suction for forcibly withdrawing inflation fluid from the balloon when it is desired to deflate the balloon down to a minimum size. The non-collapsing nature of the lumens means that the lumens obstruct collapsing of the main tubular element. The auxiliary lumens are relatively small to minimize this obstructing effect, and enable the main tubular element to collapse to a desirably small form.
U.S. Patent Publication No. 2008/0312614 describes an ileostomy set used for drainage and collection of fluid/feces from the small intestine. This set includes a balloon catheter equipped with two balloons, a fixation balloon which is inflated in the large intestine and a blocking balloon which is inflated in the small intestine behind the Bauhin valve. Each of the balloons fills the entire lumen in which it is placed. The point at which a desired inflation pressure is reached in each of the balloons, with respect to the volume of inflation fluid used, is an important characteristic to assess whether each balloon is a correct size for the large and small intestine of the patient.
It would be desirable to further enhance the versatility and ease of use of such rectal drain appliances.